Clinical Research Coordinator A/B
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
We are looking for a highly motivated, dedicated and enthusiastic individual who will provide study coordination for patient-oriented clinical and translation research projects within the Division of Rheumatology.
Clinical Research Coordinator A job duties:
- Daily coordination of multiple sponsored clinical trials and investigator-initiated research. Recruit, screen, & enroll potential study patients as specified per protocol. Schedule patient visits & any necessary testing/specimen collection.
- Process and ship blood, urine, tissue and serum specimens.
- Prepare and process Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
- Coordinate, organize, complete, and maintain all documentation required by sponsor or clinical research organizations (CROs) including source documentation, case report forms, essential study documents, regulatory documents, and patient binders. Enter data in electronic data capture systems.
- Work with research sponsors, CROs, or regulatory agencies on study initiation, monitoring, closeout visits, and any audits.
- Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
The Clinical Research Coordinator B will undertake the duties outlined for the Clinical Research Coordinator A position, with the additional expectations that he/she will improve the current infrastructure and efficiency of patient recruitment. In addition, he/she will be expected to develop novel solutions to research questions in addition to employing established methods.
Position contingent upon funding.
CLINICAL RESEARCH COORDINATOR A:
- BA/BS and 1 to 3 years clinical trial/clinical research experience or an equivalent combination of education and experience required. Effective problem-solving abilities.
- Effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. Willing to learn about, and perform work with, phlebotomy. Knowledge of IRB and human research protection regulations.
CLINICAL RESEARCH COORDINATOR B:
Same as above with 2 to 4 years of experience or an equivalent combination of education and experience required. Effective problem-solving abilities; detail-oriented; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Proficient in Microsoft Windows including Microsoft Excel and in using the internet as well as databases such as REDCAP. Prior clinical trial experience is preferred.
The ideal candidate has the duty to understand the role of the CRC as the intersection of study execution, customer service, subject safety, and overall compliance in clinical research. To this end, the proper candidate will be expected to have a strong foundation in clinical research regulations and operations through direct experience in the role.
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.